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AOA Accreditation

Accreditation Requirements for Category 1 CME Sponsors

Foreward

The AOA Board of Trustees is the only body entitled to establish accreditation policy for osteopathic CME sponsors.

The Council on Continuing Medical Education (CCME) has been delegated authority by the AOA Board of Trustees to conduct accreditation Document Surveys and On-Site surveys of CME sponsors, evaluate the survey reports, grant or deny accreditation, and establish program fees.

The Council on Continuing Medical Education is devoting increased attention to the educational quality and value of programs approved for AOA-CME credit. While “quality” and “value” admittedly are subjective, there are methods of evaluation that may determine if an educational activity does in fact meet educational needs.

Societal forces led to the support of mandatory CME and therefore, methods of evaluation of CME programs have been developed and will be an integral part of all programs approved by the AOA. AOA accredited CME sponsors shall produce documentary evidence that their educational programs are designed to improve physician competence.

This Web site is published to assist sponsors of osteopathic continuing medical education in the planning, presentation, and evaluation of programs, in order that they may be granted and continue with Category 1 accreditation.

Upon recognition as accredited, each sponsored program will be granted acceptability for Category 1 credit prior to actual start of the program. The awarding of credit, however, will not be issued until the program is verified as satisfactorily completed.

In applying for AOA accreditation CME sponsors agree to follow the basic guidelines, presented on this site to ensure that programs will be meaningful educational experiences.

These guidelines were prepared with the view that established standards will provide a means whereby the individual physician may more readily determine if programs being offered meet that individual’s personal educational needs.

Additional categorical credit is given as stated in the AOA CME Guide.

Application Procedures

Communications

All communications regarding CME accreditation shall be directed to the:

New applications

Each CME sponsor seeking AOA accreditation as a Category 1 CME sponsor shall complete the annual report, disclosure statement forms and agree to abide by these Accreditation Requirements and by the Uniform Guidelines for Accrediting Agencies of Continuing Medical Education as adopted by the AOA, (“Uniform Guidelines”).

Applications are reviewed by the AOA Division of Continuing Medical Education.

Accreditation of CME sponsors is not transferable or assignable to another entity. A Category 1 CME Sponsor must make a new application for accreditation as a Category 1 CME Sponsor if it has a significant change in its organizational structure, including but not limited to the purchase, sale, divestiture, merger, or acquisition of the Category 1 CME Sponsor.

A change in the name of the CME sponsor without other organizational changes is not considered a significant change in the organizational structure and does not require a new application. However, the CME sponsor must notify the AOA Division of Continuing Medical Education of such a name change.

Monitoring Authority

The Council on Continuing Medical Education and AOA staff will monitor these policies and procedures on an ongoing schedule, spot monitor CME programs for compliance with AOA policy and the approved “Uniform Guidelines,” and investigate all written complaints of deviation from AOA policy using a standard complaint review procedure.

Council on Continuing Medical Education authority and procedure

1. The AOA Board of Trustees is the only body entitled to establish accreditation policy for osteopathic CME sponsors.

2. The Council on Continuing Medical Education (CCME) has been delegated authority by the AOA Board of Trustees:

b. To evaluate the survey reports and other relevant information, and on the basis of the survey review, grant or deny accreditation.

3. Accreditation actions that may be recommended are:

a. Accreditation.

b. Accreditation with warning. (Private status)

c. Accreditation with probation. (Announced)

d. Denial of accreditation. (Announced)

4. Levels of sanctions may be exercised by the AOA staff and the Council on Continuing Medical Education as follows:

a. Sponsors with no deficiencies will be awarded accreditation for a 3-year period. (CCME function)

b. Sponsors with deficiencies will be awarded accreditation with warning for a 1-year term. A plan of corrective action must be completed within 60 days of the cited deficiencies and demonstrate full compliance.

A document survey will take place at the end of the 1-year term. If this survey demonstrates deficiencies, then the Sponsor will be placed on accreditation with probation for a 1-year term. A plan of corrective action must be completed within 60 days of the cited deficiencies and must demonstrate full compliance. If Sponsor fails to demonstrate full compliance, an on-site evaluation will occur after the probationary period (3rd year). If the Sponsor fails to demonstrate compliance with the on-site survey, then the Sponsor may be denied accreditation (CCME function).

Survey Procedures (Document Survey or On-Site Survey)

1. Sponsors who are in full compliance will have a Document Survey at least once every three years (see Appendix D).

2. Sponsors who do not demonstrate full compliance will have a document survey and/or site survey according to the accreditation actions described in Section IIA4b of this document.

Reconsideration and/or Appeal Procedures

1. CME sponsors may request a reconsideration of an accreditation action by the Council on Continuing Medical Education or appeal to the Bureau of Professional Education.

a. A request for reconsideration or a request for appeal will include a detailed description of errors in fact from the survey report, andthe documentation of correction of noncompliance areas whenever possible.

b. The reconsideration/appeal procedures permit the CME sponsor to show that it has corrected or is attempting to correctdeficiencies that were found at the time of survey.

c. Presentation of such corrections does not bind the CCME or the Bureau to either reverse or accept the initial recommendations of the CCME.

d. CME sponsors requesting appeals are automatically continued on their current accreditation status until the appeal hearing has been conducted and recommendations made and acted upon by the AOA Bureau of Professional Education.

2. Requests for reconsideration must be made in writing to the Council on Continuing Medical Education, and must be filed within 30 daysfollowing receipt of the recommendation of the Council on Continuing Medical Education.

3. Requests for appeal must be made in writing to the Bureau of Professional Education, and must be filed within 30 days following receipt of the action by the Council on Continuing Medical Education.

4. CME sponsors may seek a final appeal and hearing before the AOA Board of Trustees.

Appendix A: AOA Guidelines for industry gifts to physicians

The American Osteopathic Association recommends the following guidelines to its members for their professional conduct in reference to gifts and subsidies offered to them by representatives of the pharmaceutical and medical equipment industries:

1. Gifts to physicians should be related to patient care or medical practice; they should be of modest value. Gifts of cash should not be accepted.

2. Individual physicians should not accept financial subsidies from industry to defray the cost of attendance at professional conferences.

3. Financial support or gifts from industry for transportation, lodging, and related expenses for trips which are for primarily recreational and social functions should not be accepted.

4. Gifts by industry to students, interns, residents, and fellows for professional travel are appropriate if the recipient is selected by the college, training institution or the sponsor of theeducational event.

Interpretive Guideline:

Unacceptable gifts include cash, subsidies for travel, lodging or personal expenses, or in compensation of time spent for physicians attending conferences or meetings; payment for token focus groups, token consulting and advisory services; and gifts with “strings attached’ such as those given in relation to a physician’s prescribing practices.

Acceptable gifts include textbooks and other educational gifts not of substantial value; work-related gifts of minimal value (i.e., pens, notepads and penlights, etc.); scholarships for medical students and residents to attend educational conferences, if selection and payment is made by the academic institution; reasonable compensation and reimbursement of expenses sustained by consultants; and modest meals, usually in conjunction with educational programs.

The AOA also recommends support of the Pharmaceutical Manufacturer’s Association guidelines.

Appendix B: Definition of Terms

Terms used in this CME Accreditation site are related to the Federal Food, Drug, and Cosmetic Act, the Uniform Guidelines, and the Accreditation Requirements for AOA Category 1 CME Sponsors.

This list of terms has been compiled to furnish users of the document, American Osteopathic Association Accreditation Requirements for AOA Category 1 CME Sponsors, with a common terminology. The availability of the glossary, it is hoped, will lead to a clear understanding of the intent of these Requirements and Guidelines.

Accredited Sponsor

An AOA-CME Category 1 sponsor is an institution, organization or affiliate that is accredited by the AOA Council on CME to present programs that qualify for AOA-CME category 1 credit.

Formal Osteopathic Sponsors

are limited to AOA recognized osteopathic institutions, organizations, or affiliates that present programs for Category 1-A or 1-B credit. The following may apply for such recognition (this recognition is not automatic).

A. AOA accredited colleges of osteopathic medicine and hospitals, or hospitals directly affiliated with a college of osteopathic medicine.

E. Osteopathic organizations sponsored by or affiliated with AOA affiliates or divisional societies.

Accredited sponsors have the discretion of allowing other non-AOA accredited organizations, termed “Providers” to conduct CMEprograms under their accreditation status. It is the Accredited Sponsor’s responsibility to ensure that the Provider’s programs willfollow the AOA Category 1 CME Requirements.

Accrediting

The FDA, in exercise of its administrative discretion, will seek to rely to the extent possible on major accrediting organizations to monitor company-supported educational activities conducted by their accredited providers and ensure that such activities are independent and nonpromotional.

Act

Federal Food, Drug, and Cosmetic Act

Advertisement

Being generally applied to the universe of industry promotional activities designed to provide information on regulated products, but do not fall within the definition of labeling. The promotion of an off-label use, whether or not in a form deemed to be an advertisement, may give rise to a violation of the labeling provisions of the Act.

Agency

Food and Drug Administration (FDA)

Agency Policy

Covers not only human drugs, which were the subject of the concept paper, but also covers devices, biologics, and veterinary medicines, which are all subject to regulation with regard to labeling and advertising.

Enduring Materials

Commercially supported enduring materials are planned educational programs and materials designed and developed with financial or other support from commercial interests, and used for CME purposes beyond their initial presentation. Such enduring materials include printed, photographed, or electronically modulated programs and materials, such as, but not limited to, printed educational material, audio cassettes, video cassettes, computer assisted instruction, broadcast by television or radio of any type, and electronic teaching aids.

Labeling

Include not only product labels but also other written, printed, or graphic matter that “accompanies” a product.

Program

A formal educational program presented in a live setting.

Provider

A non-accredited organization which provides CME programs under the discretion and approval of an AOA Accredited Category 1 CME Sponsor.

Regulated Industry

Persons or entities that manufacture, sell, or conduct research on human and animal drugs, biological products, and medical devices.

Safe Harbor

Scientific and educational activities that are supported by the regulated industry but are independent of promotional influences that may emanate from the supporting companies. Within the perimeters of the safe harbor, activities may be funded by the regulated industry, may be designed to provide information on the use of regulated products, and yet be left free from regulation under the labeling and advertising provisions of the Federal Food, Drug, and Cosmetic Act.

Safe harbor is based not on a distinction between promotion and education, but rather on a distinction between activities that aresubject to influence by the regulated industry and independent activities that are free from promotional influences. Educational value does not provide a safe harbor from agency regulation; educational activities that are designed or influenced by the regulated industry, even if of the highest educational quality, are subject to regulation.

The general characteristics of the traditional safe harbor for industry-supported scientific and educational activities are (1) anunderstanding between the provider and supporting company that the activity is to be a scientific or educational activity, and not designed to promote the supporting company’s product, (2) functional independence on the part of the provider from influence over content by the supporting company, and (3) adequate disclosure of supporting company involvement.

Sponsors Overall Program

The range and scope of CME (clinical educational) activities which are offered by an AOA accredited CME sponsor.

Uniform Guidelines

Uniform Guidelines for Accrediting Agencies of Continuing Medical Education as adopted by the AOA.

Written Agreement

Companies and providers who wish to ensure that their activities will not be subject to regulation should design and carry out their activities based on written agreement between the company and the provider documenting that the provider will be solely responsible for designing and conducting the activity, and that the program will be educational and non-promotional in nature.

The written agreement shall provide for appropriate disclosure. If the company abides by such an agreement and does not otherwisecircumvent the purpose of the agreement, the FDA does not intend to regulate the activity under the labeling and advertisingprovisions of the Federal Food, Drug, and Cosmetic Act.

Appendix C: Instructions for Completing Category 1 Sponsor

Accreditation Application Form

The following form (in PDF) should be completed in duplicate. Forward the original copy to:

Accreditation Requirements for AOA Category 1 CME Sponsors

Please consult these documents prior to submission of this application form.

The Sponsor Accreditation Application Form is in PDF format, which can be opened using Adobe Acrobat Reader. This is a free program that takes a few minutes to download into your computer. If you already have Reader installed on your computer, make sure you’re running theversion 4.0 or higher.

This may take a few minutes to download. You can type in the form directly on your screen before you print and sign it for mailing. (PDF: 51KB / 3 pages)

Appendix D: Document Survey Protocol

The AOA Council on CME is responsible for monitoring the compliance of AOA Category 1 CME Accredited Sponsors with the AOA Category 1 CME Accreditation Requirements. The following protocol has been adopted by the AOA Board of Trustees at its meeting of February 17-19, 1995, to monitor the programs of AOA Category 1 CME Accredited Sponsors without the necessity of conducting on-site surveys.

On-site surveys may be performed however, if an organization is found to be noncompliant with the following regulations or if a physician or other individual attending an accredited sponsor’s CME program reports an error or fraudulent action per the AOA’s Category 1 CME Accreditation Requirements. The action of conducting an on-site survey will be determined at the discretion of the Council on Continuing Medical Education.

Document Survey Procedure:

1. All accredited AOA Category 1 CME Sponsors will be required to submit to the AOA Division of CME an annual listing of all CME programs sponsored within the past twelve months. This listing must be received by the Division of CME within 30 days receipt of the request.

2. The AOA Division of CME will review this listing of CME programs and select an appropriate number for review.

3. The AOA will then notify the sponsoring organization of the programs chosen for review via certified mail and will ask the organization to submit the required information within thirty working days of notification.

4. The requested information will be reviewed by the AOA Division of CME and the results of this review will be forwarded to the Council on CME, who will determine the accreditation status of the applying organization at the next CCME meeting.

5. If deficiencies are found, organizations will be notified of them and given a 60-day period to respond with a plan of corrective action which will be reviewed by the AOA Division of CME.

6. Failure to submit the required documentation, or failure to respond to deficiencies within the 60-day period may result in an on-site visit and survey and/or the initiation of procedures which would lead to the loss of AOA Category 1 CME Sponsor Accreditation status.

Survey Requirements:

The following items are requested for document survey review for the CME program(s) chosen:

A copy of the brochure or agenda distributed to participants at the CME program.

A description of the needs assessment process used in determining the content of the program, along with any supporting documents. Please include a statement pertaining to how topics and/or speakers were selected in direct response to needs assessment procedures.

Copies of the program participant’s (speakers and moderators) curriculum vitae if available, or brief biosketch defining their qualifications for involvement in your CME programs.

A copy of the speakers’ signed Disclosure Declaration Statement.

Evidence of sponsor monitoring of CME participation by physicians (i.e., a copy of the sign-in sheet from the program).

A copy of CME hours requested by the accredited sponsor for each participating physician (i.e., according to the sign-in sheets).

A copy of the program administration and evaluation document and two examples that were returned by conference participants. In addition, a count of the number of evaluation documents returned by registrants should be listed as well as a statement as to how these forms are distributed (i.e., the beginning of the program, random survey, etc.)

A policy on managing grievances related to the returned program administration and evaluation document.

Indication of whether or not the program(s) was commercially supported. If the program was commercially supported, the following additional items must be submitted:

A) A copy of the formal written agreement between the Accredited Sponsor and the Commercial Supporter reflecting that the activity is to be educational and non-promotional.

B) Proof that the commercial support is appropriately acknowledged in announcements and brochures.

C) A brief statement regarding the funding arrangements to include how funds received fromcommercial supporters were expended, and how speakers were paid if directly funded by a third party agent (someone besides the sponsor/provider) along with a copy of the funding arrangement between the sponsor and the third party agent.

D) Documentation as to how disclosure information regarding each speaker was given to the participants.

E) A statement regarding how the commercial exhibit area was arranged, i.e., were promotional activities provided in a separate room, or an arranged exhibit hall which included exhibits from alternative companies

Appendix E: On-site Survey

On-site SurveyThis may take a few minutes to download. (PDF: 49KB / 16 pages)

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